Find Associate director, reporting & insights partner r&d & technical operations Jobs in Dublin West, D

Associate Director, Pharmacovigilance Operations (Contract)
PTC Therapeutics International Limited —DUBLIN 2, County Dublin
- Full-time
- Management
- Microsoft Office
- Bachelor's degree
Quick apply
5d
Associate Director, Pharma Account Manager
Optum —Dublin, County Dublin
- Full-time
- Management
- Master's degree
- No degree
Internal Audit - Senior Associate
PwC —Dublin, County Dublin
- Full-time
- Bachelor's degree
- Accounting
- Business
Associate Technical Director - Civils & Structural Lead
Arcadis —Dublin, County Dublin
Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Bachelor's degree
- No degree
- In-person
- Annual leave
Senior Surveyor (Associate/Divisional Director)Professional Services
BNP Paribas —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Associate Director, Pharmacology
Grifols Worldwide Op Ltd —Dublin, County Dublin
- Full-time
- Doctoral degree
Senior Producer
Virtuos Games —Dublin, County Dublin
- Full-time
- English
- Analysis skills
- Project management
- Sick pay
Data & AI Consultant – Associate Director - ROI / Belfast
Grant Thornton —Dublin, County Dublin
- Full-time
- Azure
- SQL
- Business development
12d
Associate Director, R&D Project Finance
Jazz Pharmaceuticals —Dublin, County Dublin
- Microsoft Excel
- Oracle
- Finance
- Annual leave
2d
Associate Director
Cushman & Wakefield —DUBLIN 2, County Dublin
- Full-time
- Business development
- Negotiation
Quick apply
PGIM | Director, Designated Person For Fund Risk (PCF 39C)
PGIM —Dublin, County Dublin
- Full-time
- Python
- Annual leave
Associate Director (Water)
AtkinsRéalis —Dublin, County Dublin
- Full-time
- Hybrid work
- Leadership
Associate Director Corporate Security
UnitedHealth Group —Dublin, County Dublin
- Full-time
- Analysis skills
- Leadership
- Communication skills
13d
Associate Director, Pharma Strategy
Optum —Dublin, County Dublin
- Full-time
- Master's degree
- Business development
- Bachelor's degree
10d
Account Management, Associate Director - Healthcare Data & Technology
IQVIA —Dublin, County Dublin
- Full-time
- Master's degree
- Business development
- Bachelor's degree
Associate Director, Supply Chain Business Support (Remote / Home Based)
Jazz Pharmaceuticals —Dublin, County Dublin
- Engineering
- Business
- Communication skills
- Annual leave
Mechanical Associate Director: Data Centres
AECOM —Dublin, County Dublin
- Full-time
- Leadership
FS Project Manager – Associate Director - Dublin / Belfast
Grant Thornton —Dublin, County Dublin
- Full-time
- Management
- Business development
- Analysis skills
Associate Director - MLRO
Waystone —Dublin, County Dublin
- Full-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Continuous improvement
Quick apply
4d

I want to receive the latest job alerts for associate director, reporting & insights partner r&d & technical operations in dublin west, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

associate director, reporting & insights partner r&d & technical operations jobs near dublin west, d

Account Manager jobs in Dublin, County Dublin

Technical Lead jobs in Dublin, County Dublin

Director Of Security jobs in Dublin, County Dublin

Associate Director jobs in Dublin, County Dublin

Internal Auditor jobs in Dublin, County Dublin

Project Director jobs in Dublin, County Dublin

Director Of Strategy jobs in Dublin, County Dublin

Senior Producer jobs in Dublin, County Dublin

R&D Engineer jobs in Dublin, County Dublin

Data Consultant jobs in Dublin, County Dublin

Account Manager jobs in Clonmel, County Tipperary

Account Manager jobs in Capppancur, County Offaly

Business Development Manager jobs in Dublin, County Dublin

Account Manager jobs in Limerick, County Limerick

Reservations Manager jobs in Dublin, County Dublin

Account Manager jobs in Cork, County Cork

Quantity Surveyor jobs in Louth, County Louth

Quantity Surveyor jobs in Ballinteer, County Dublin

Sales Surveyor jobs in Dublin, County Dublin

Junior Quantity Surveyor jobs in Limerick, County Limerick

Associate Director, Pharmacovigilance Operations (Contract)

PTC Therapeutics International Limited -
DUBLIN 2, County Dublin

Quick apply

Job details

Full-time
5 days ago

Qualifications

Biology
Management
Microsoft Office
Bachelor's degree
Data entry
Communication skills
Time management

Full job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Associate Director, Pharmacovigilance Operations oversees Pharmacovigilance Operations activities, both internally supported and outsourced, including the collection, processing, assessment, monitoring and follow-up of all types of safety information from various sources, including clinical trials and post-marketing, and any other PV Vendor deliverable
The incumbent ensures all relevant Pharmacovigilance guidelines / regulations are adhered to and works cross-functionally with internal departments and external resources on ICSR and safety database related matters. This includes providing strategic and operational oversight of PTC’s Pharmacovigilance (PV) vendor.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Leads, oversees and actively contributes to the development, implementation and maintenance of a robust safety reporting system compliant with current applicable regulations. This includes closely managing the PV vendor and the case workflow, reviewing samples of cases to ensure ICSR quality and compliance with regulatory timeframes.
Supports training the PV vendor on new products and compliance requirements.
Supports PV set up and implementation of new studies / programs, including interventional Clinical Trials and Post-authorisation safety studies.
Reviews and contributes to PV vendor operational documentation, e.g. operational plans, program specific work-instructions.
Oversees safety database configuration, ensuring it meets applicable regulations and program needs.
Ensures the quality, completeness and timeliness of delivery of all outputs from the safety database supporting routine safety oversight activities, aggregate reports, ad-hoc Health Authority request etc.
Supports PTC’s PV strategic business continuity plan.
Authors ICSR-related processes and assists with the development, implementation and on-going enhancement of related SOPs.
Maintains and archives manual and electronic drug safety files pertaining to ICSR management.
Performs other tasks and assignments as needed and specified by management including line management

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Describe the following criteria, which are necessary to effectively perform the position:

Minimum level of education and years of relevant work experience.
BSN/RN, Bachelor’s degree in Biological Sciences, Pharmacy or PharmD degree preferred and a minimum of 7 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership role within pharmacovigilance operations.
Special knowledge or skills needed and/or licenses or certificates required.

Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.
Demonstrated hands-on experience with Argus Safety database.
Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g., SAE reporting throughput rate).
Demonstrated ability to identify opportunities to improve the PV reporting process(es).
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Special knowledge or skills and/or licenses or certificates preferred.

Understanding of safety database administration, configuration, data entry and extraction.
Expertise in the use of Electronic Document Management System (eDMS) software.
Expertise in WHODD with relevance to coding suspect drug and concomitant medications.

Travel requirements

0-10%

Physical requirements (only note if the job requires physical capacity beyond general office work)

Office / Remote based position

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Click here to return to the careers page

Quick apply

Refine Your Search

associate director, reporting & insights partner r&d & technical operations jobs in dublin west, d

Associate Director, Pharmacovigilance Operations (Contract)

Associate Director, Pharma Account Manager

Internal Audit - Senior Associate

Associate Technical Director - Civils & Structural Lead

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Senior Surveyor (Associate/Divisional Director)Professional Services

Associate Director, Pharmacology

Senior Producer

Data & AI Consultant – Associate Director - ROI / Belfast

Associate Director, R&D Project Finance

Associate Director

PGIM | Director, Designated Person For Fund Risk (PCF 39C)

Associate Director (Water)

Associate Director Corporate Security

Associate Director, Pharma Strategy

Account Management, Associate Director - Healthcare Data & Technology

Associate Director, Supply Chain Business Support (Remote / Home Based)

Mechanical Associate Director: Data Centres

FS Project Manager – Associate Director - Dublin / Belfast

Associate Director - MLRO

I want to receive the latest job alerts for associate director, reporting & insights partner r&d & technical operations in dublin west, d

Related Searches

Explore jobs in more locations

Job Description Summary:

Job Description:

Jobseeker tools

Employer Tools

Browse

Stay Connected